Cleared Special

Smylio Invisible Clear Aligners (K212660) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212660 · Smylio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
30d
Days
Class 2
Risk

K212660 is an FDA 510(k) clearance for the Smylio Invisible Clear Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Smylio, Inc. (Fremont, US). The FDA issued a Cleared decision on September 22, 2021 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smylio, Inc. devices

Submission Details

510(k) Number K212660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2021
Decision Date September 22, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Prime Path Medtech
Breanne Butler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K212660.
QuickAligners
K211537 · Oral Image, Inc. · Oct 2021
Clear Aligner
K203688 · Wuxi EA Medical Instruments Technologies Limited. · Oct 2021
Inman Digital Clear Aligners
K210763 · Inman Orthodontic Laboratories, Inc. · Sep 2021
SMILERS
K212961 · Biotech Dental Smilers, Sas · Sep 2021
Clear Aligners
K210373 · Shenzhen Yinuo Dental Technology Co.Ltd · Aug 2021
ClearCorrect System
K210320 · Clearcorrect, LLC · Aug 2021